Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT00577629
Phase
PHASE2
Status
Completed

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cyclophosphamide — DRUG
    1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2
  • etoposide — DRUG
    300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.
  • rituximab — DRUG
    375mg/m2 each week x 4 weeks of induction, beginning on day 1
  • cytarabine — DRUG
    3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
  • doxorubicin — DRUG
    45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
  • tositumomab — DRUG
    450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Study Details

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

Key Dates

First listed
Dec 20, 2007
Start date
Jun 18, 2005
Status verified
Apr 2017
Primary completion
Apr 8, 2012
Completion
Nov 3, 2016

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Induction + Consolidation + Bexxar
    Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)

Primary Outcome Measure

1 Year Progression-free Survival Rate [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

Related Studies